1. Decide if JSP536 applies to a research project

The decision as to whether a protocol requires review lies with the Research Sponsor in collaboration with the Chief Investigator. All research has a research sponsor. This is the organisation that takes final, legal responsibility for a piece of research, and is often the employer of the Chief Investigator. The Sponsor and Chief Investigator should familiarise themselves with JSP536, and then work through the following checklist to determine whether the research project falls under the remit of JSP536. If you are in any doubt as to whether review is necessary please contact the MODREC Secretariat for additional advice.

If you think your study requires a Clinical Trials Authorisation, or is studying a non-CE marked medical device, please contact the MODREC Secretariat prior to submitting your application to receive further guidance.

Read JSP536 part 2 annex 1A for more information.

2. Complete Sponsors Checklist and Scientific Assessment Committee (SAC) review

The Sponsors Checklist must be completed before a study is submitted to MODREC for ethics review.

A SAC review is a separate process that occurs prior to MODREC review. SAC approval is required to complete the Sponsors checklist. Please identify a relevant SAC and contact them for details of their review process.

The checklist can be found in JSP536 part 2 annex 1B.

3. Submit Sponsors Checklist and MODREC application form to MODREC secretariat

Applications to MODREC must be made on the application form template (MS Word Document, 120 KB).

Send your Sponsors Checklist and application form, along with any supporting documentation (participant information sheets, consent forms etc.) by email to the MODREC Secretariat. Applications should be sent as a single MS Word document with all parts having unique sequential page numbers.

4. Receipt of application form

The MODREC Secretariat will triage and formally register the submitted application and determine whether the application requires “Proportionate Review” (see JSP536 part 2 chapter 4) or a full committee review.

5. MODREC review

If a project is suitable for a proportionate review by MODREC, researchers will receive a decision within 20 working days of a validated application. Researchers will not be required to attend a MODREC meeting, all correspondence will be via email from the secretariat.

If a full MODREC review is required, MODREC aims to meet on a monthly basis, usually on the first Tuesday of each month. The Chief Investigator will be invited to attend the review to address any queries and/or concerns raised by MODREC.

MODREC will provide a formal decision on the application as soon as practicable, and will provide formal feedback within 10 working days of it being considered at the meeting.

6. Commencing the research

Once a favourable opinion has been received from MODREC (through either proportionate or full committee review) permission to commence the research can be provided by the Research Sponsor.

7. Reporting and Monitoring Requirements

Research Sponsors and Chief Investigators must familiarise themselves with the monitoring and reporting requirements laid out in JSP536 part 2 chapter 9.

8. Final Report

A summary of the final report on the research must be submitted to MODREC within one year of the conclusion of the research. A template for final reports is included in JSP536 part 2 Annex 9A. As a minimum, MODREC should receive information on whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research including any feedback to participants.

Who to contact

See also the full list of contacts for each of the scientific advisory committees.